FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069283 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 18/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective observational study 
Study Design  Single Arm Study 
Public Title of Study   Prediction of difficult laryngoscopy by ultrasound measurement of face and neck parameters in adult patients. 
Scientific Title of Study   ULTRASOUND BASED ASSESSMENT OF TONGUE THICKNESS, SKIN TO HYOID BONE DISTANCE AND SKIN TO EPIGLOTTIS DISTANCE IN PREDICTING DIFFICULT LARYNGOSCOPY IN ADULT PATIENTS. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kushal Dabas 
Designation  Post graduate resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, New Delhi India New Delhi DELHI 110029 India

South
DELHI
110029
India 
Phone  8130034071  
Fax    
Email  kushal.dabas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anjali Kochhar 
Designation  Associate Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, New Delhi New Delhi DELHI 110029 India

South
DELHI
110029
India 
Phone  9999197721  
Fax    
Email  dranjalikochhar@vmmc-sjh.nic.in  
 
Details of Contact Person
Public Query
 
Name  Anjali Kochhar 
Designation  Associate Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi, New Delhi New Delhi DELHI 110029 India

South
DELHI
110029
India 
Phone  9999197721  
Fax    
Email  dranjalikochhar@vmmc-sjh.nic.in  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,New Delhi 110029 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,New Delhi 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kushal Dabas  Vardhman Mahavir Medical College and Safdarjung Hospital  Department of anaesthesia,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,New Delhi New Delhi DELHI
South
DELHI 
8130034071

kushal.dabas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vardhman Mahavir Medical College and Safdarjung Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients aged between 18-65years, undergoing elective surgery under general anaesthesia requiring endotracheal intubation. 
 
ExclusionCriteria 
Details  1) Anticipated difficult airway requiring planned awake intubation.
2) Front of neck access not available. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the role of ultrasound based assessment of combination of tongue thickness, skin to hyoid bone distance and skin to epiglottis distance in predicting difficult laryngoscopy in
adult patients, using Cormack Lehane grading. 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To compare ultrasound based assessment of combination of tongue thickness, skin to hyoid bone distance & skin to epiglottis distance with each individual parameter in predicting difficult laryngoscopy in adult patients undergoing elective surgery.  At the time of induction of anaesthesia 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Difficult intubation is an emergency situation and an important procedural step during anaesthesia, and failure to anticipate difficult intubation can have serious consequences like local injury, hypoxia, need of putting surgical airway, arrhythmia, cardiac arrest and death. The incidence of difficult laryngoscopy and tracheal intubation still ranges between 1.5%-13%.

An accurate pre-operative assessment therefore provides comprehensive planning and management for reducing the risk of unanticipated difficult airway. However, common clinical evaluation measurements (e.g. the modified Mallampati test, thyromental distance, inter-incisor distance, cervical mobility, sex, body mass index, etc.) have limited value with unsatisfactory sensitivity and specificity.

Tongue thickness assessed by USG gives us an internal characteristic of a patients upper airway and helps us in predicting difficult laryngoscopy. It will be determined by placing curvilinear ultrasound probe one end against top of the mandible and other end to the sternum. 
 
Skin to epiglottis distance tells us about width of anterior soft tissue of neck at the level of thyrohyoid membrane. It will be determined by placing linear probe at thyrohyoid membrane level, the distance from skin to epiglottis midway between the hyoid bone and thyroid cartilage is measured. 

Skin to hyoid bone distance tells us about the anterior soft tissue thickness of neck at the level of hyoid bone. The hyoid bone is identified by placing the linear ultrasound probe transversely over the hyoid bone. It appears as curved echogenic structure with a bright posterior air mucosal interface and hyperechoic pre-epiglottic space. At hyoid bone level, the minimal distance from skin to hyoid
bone will be measured.

However, difficult airway is not determined by a single anatomical factor, and the sensitivity and specificity of a single index for airway prediction are not ideal. Also, there is a paucity of data on the role of ultrasound measurement of combination of airway parameters in predicting difficult laryngoscopy in adult patients.

The purpose of this study is to evaluate the role of ultrasound based assessment of tongue thickness, skin to hyoid bone distance and skin to epiglottis distance in predicting difficult laryngoscopy in adult patients.
 
Close